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Purdue Pharma L.P. v. Mylan Pharmaceuticals Inc.

United States District Court, D. Delaware

March 1, 2017

PURDUE PHARMA L.P. et al., Plaintiffs,
v.
MYLAN PHARMACEUTICALS INC. and MYLAN INC., Defendants.

          REPORT AND RECOMMENDATION

          SHERRY R. FALLON, UNITED STATES MAGISTRATE JUDGE

         I. INTRODUCTION

         Presently before the court in this patent infringement action is a motion to dismiss for failure to state a claim upon which relief can be granted pursuant to Federal Rule of Civil Procedure 12(b)(6), filed by defendants Mylan Inc. ("Mylan") and Mylan Pharmaceuticals Inc. ("MPI") (collectively, "defendants"). (D.I. 23) For the following reasons, I recommend that the court deny the motion.

         II. BACKGROUND

         A. The Patent-In-Suit

         This action arises out of defendants' submission of Abbreviated New Drug Application ("ANDA") No. 203915 to the United States Food and Drug Administration ("FDA") on November 2, 2015. (D.I. 1 at ¶¶ 1> 31) Plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F. Laboratories, Inc., and Rhodes Technologies (collectively, "plaintiffs") assert that defendants' ANDA filing constitutes infringement of United States Patent No. 9, 073, 933 ("the '933 patent"), which relates to plaintiffs' OxyContin® brand oxycodone hydrochloride. (Id. at ¶¶ 1-2) OxyContin® is an extended-release pain medication. (Id. at ¶ 2)

         The '933 patent, entitled "Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone, " was issued on July 7, 2015, naming Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle, and Robert Kupper as the inventors. (Id. at ¶ 30) The '933 patent is directed to an oxycodone hydrochloride active pharmaceutical ingredient ("API") with low levels of 14-hydroxycodeinone ("14-hydroxy"), and the processes for making the oxycodone hydrochloride composition. ('933 patent, col. 1:25-27) 14-hydroxy belongs to a class of potentially toxic compounds known as alpha, beta unsaturated ketones ("ABUKs") found in oxycodone compositions. (Id. col. 6:51-54); Chapman v. Casner, 315 F.App'x 294, 295 (Fed. Cir. 2009).

         In a July 1, 2014 office action, the United States Patent and Trademark Office ("PTO") issued a non-final rejection of then-pending claims 71-90 of the '933 patent as unpatentable for obviousness-type double patenting[1] over certain prior art references. Specifically, the examiner rejected the claims as being unpatentable over claims 1 to 14 of U.S. Patent No. 7, 683, 072 ("the '072 patent"), claims 1 to 9 of U.S. Patent No. 7, 674, 799 ("the '799 patent"), and claims 38 to 55 of U.S. Patent No. 7, 674, 800 ("the '800 patent;" together with the '072 patent and the '799 patent, the "low-ABUK patents"), among others.[2] (D.I. 25, Ex. 8 at 7/1/14 Office Action, ¶¶ 10, 12, 13) The low-ABUK patents share a common specification and priority date with the '933 patent and, like the '933 patent, are directed to reducing the amount of 14-hydroxy in an oxycodone hydrochloride preparation.

         In response to the obviousness-type double patenting rejection, plaintiffs filed terminal disclaimers on October 1, 2014[3] to dispose of the double-patenting rejection, stating that "[a]pplicants traverse these rejections, but submit herewith terminal disclaimers ... in an effort to expedite prosecution." (Id., 10/1/14 Response at 13) Plaintiffs expressly stated that "[t]hese terminal disclaimers are being submitted solely for the purpose of removing the double patenting rejections. The filing of these terminal disclaimers is neither an admission of the propriety of the rejections nor an admission that the inventions claimed in present claims 71-90 are not 'independent and distinct' from the inventions of the low-ABUK patents. (Id.)

         The PTO issued a final rejection of the '933 patent application on October 31, 2014, rejecting claims 71-90 as obvious under § 103 after concluding that it would have been obvious to one skilled in the art to prepare an oxycodone hydrochloride composition with a reduced amount of 14-hydroxy by dehydrating 8a in view of the FDA's instructions to prepare oxycodone salt with reduced amounts of 14-hydroxy. ('933 patent, 10/31/14 Final Rejection at ¶ 3) The examiner further noted that parent patent application 11/391, 897 (the "Chapman application") was invalidated based on an obviousness rejection during an interference proceeding. On January 29, 2015, the examiner held a telephonic interview with plaintiffs to discuss the adverse decision on the claims at issue in the interference proceedings regarding the Chapman application. Plaintiffs filed a response after final rejection on March 4, 2015, further amending the claims to distinguish them from the Chapman application by independently requiring 8a as an element of the claimed composition or process. The PTO issued a notice of allowance of the amended claims 71-90, renumbered as claims 1-20, on March 23, 2015, after concluding that the arguments filed on March 4, 2015 were persuasive in overcoming the obviousness rejections and the addition of the 8a limitation rendered the claims patentably distinct from the claims at issue in the Chapman interference proceedings.

         B. The Teva Litigation

         Plaintiffs previously sued Teva Pharmaceuticals, USA ("Teva") in the Southern District of New York, [4] alleging infringement of the low-ABUK patents. In re OxyContin Antitrust Litig., 994 F.Supp.2d 367 (S.D.N.Y.2014). The claims of the '799 and '072 patents are directed to oxycodone hydrochloride, with the '799 patent claiming an "oral dosage form" of low-ABUK oxycodone hydrochloride. Id. at 387-88. The asserted claims of the '800 patent recite a process for preparing an oxycodone salt substantially free of 14-hydroxy. Id. at 387. The Southern District of New York held that Teva infringed all of the asserted product-by-process claims, but concluded that those claims were invalid for obviousness pursuant to 35 U.S.C. § 103. Id. at 403 ("For purposes of validity, the Court considers only the product limitations of a claim, not process limitations or source limitations that add no patentable significance to the end product.").

         The court acknowledged that plaintiffs discovered 8a as the source of the 14-hydroxy problem, and noted that 8a was unknown in the prior art, but the court ultimately did not consider the derived-from-8a language in the low-ABUK patent claims in reaching its conclusion because process limitations in product-by-process claims are disregarded in the obviousness inquiry, and 8a was "largely irrelevant to the process used by Purdue to obtain the product claimed by the patents." Id. at 405.

         On February 1, 2016, the Federal Circuit affirmed the Southern District of New York's decision regarding the invalidity of the low-ABUK patents, relying on principles specific to product-by-process claims and concluding that the district court did not err in disregarding the 8a limitations in the obviousness inquiry. Teva, 811 F.3d at 1352-54. The district court's invalidity determination was therefore upheld with respect to claims 3 and 19 of the '799 patent, claims 30-34 and 76-79 of the '800 patent, and claims 1, 4, and 5 of the '072 patent. Id.; In re OxyContin, 994 F.Supp.2d at 438. On April 1, 2016, plaintiffs petitioned for rehearing en banc of the Federal Circuit's decision in the Teva appeal. (D.I. 28, Ex. 1) Plaintiffs' petition for rehearing en banc was denied by the Federal Circuit on May 4, 2016, and plaintiffs' subsequent petition for a writ of certiorari before the United States Supreme Court was denied on November 14, 2016. (D.I. 33; D.I. 51)

         C. The Chapman Application

         The low-ABUK patents and the '933 patent are continuations of the Chapman application, which was filed on March 29, 2006. In re OxyContin, 994 F.Supp.2d at 388. The Chapman application recited a "process for preparing oxycodone hydrochloride having less than 25 ppm [14-hydroxy]." Id. During an interference proceeding on April 19, 2007 involving claims 96-188 of the Chapman application, the Board of Patent Appeals and Interferences (the "BPAI")[5] declared an interference between the Chapman application and U.S. Patent No. 7, 153, 966 ("Casner"). On March 18, 2008, the BPAI found that independent claim 96 of the Chapman application and the dependent claims thereof were invalid as obvious in view of U.S. Patent No. 7, 153, 966 ("Casner"), and the Federal Circuit affirmed. See Chapman v. Casner, C.A. No. 08-1427, 315 F.App'x 294, 295 (Fed. Cir. Mar. 11, 2009); (D.I. 25, Ex. 10, 3/13/08 Order). The adjudicated Chapman application claims related to a method for making oxycodone API using a hydrogenation step to remove 14-hydroxy, but they did not require that some of the remaining 14-hydroxy be derived from the 8a isomer. Teva, 811 F.3d at 1349. In holding that the claims at issue were unpatentable under § 103, the BPAI relied on the lack of any reference in the claims to 8a as the source of the 14-hydroxy, noting that "[b]ecause the claims did not specify the source of the 14-hydroxy, any prior art reference that disclosed conditions under which either 8a or 80 converted to 14-hydroxy would render the claim obvious." Id. (citing Chapman, 315 F.App'x at 297). Because the prior art references disclosed conditions under which 8p converts to 14-hydroxy, the BPAI determined that the Chapman application claims were obvious in view of the prior art. Id.

         III. LEGAL STANDARD

         Rule 12(b)(6) permits a party to move to dismiss a complaint for failure to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). When considering a Rule 12(b)(6) motion to dismiss, the court must accept as true all factual allegations in the complaint and view them in the light most favorable to the plaintiff. Umland v. Planco Fin. Servs., 542 F.3d 59, 64 (3d Cir. 2008).

         To state a claim upon which relief can be granted pursuant to Rule 12(b)(6), a complaint must contain a "short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). Although detailed factual allegations are not required, the complaint must set forth sufficient factual matter, accepted as true, to "state a claim to relief that is plausible on its face." BellAtl. Corp. v. Twombly,550 U.S. 544, 570 (2007); see also Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009). A claim is facially plausible when the factual allegations allow the court to ...


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